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Original New Drug Application Approvals by US FDA (01-15 December 2023)

18 Dec 2023

New drug applications approved by US FDA as of 01-15 December 2023 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

Original New Drug Application Approvals by US FDA (01-15 December 2023)

18 Dec 2023

Zonulin a promising biomarker for preclinical coeliac disease screening

18 Dec 2023

Zonulin levels appear to substantially increase in the months leading up to a diagnosis of coeliac disease, as reported in a study. Additionally, exposure to a greater number of antibiotic courses contribute to an increase in zonulin levels in individuals with coeliac disease, highlighting a potential role for the marker in preclinical screening.

Zonulin a promising biomarker for preclinical coeliac disease screening

18 Dec 2023

AI-guided stethoscope helps detect cardiomyopathy during pregnancy

18 Dec 2023 by

A screening programme that incorporates artificial intelligence (AI)-guided digital stethoscope improves clinicians’ ability to detect peripartum cardiomyopathy in the Nigerian SPEC-AI trial.

AI-guided stethoscope helps detect cardiomyopathy during pregnancy

18 Dec 2023

$Supplementation does little to reduce fractures in schoolchildren with vitamin D deficiency$

Supplementation does little to reduce fractures in schoolchildren with vitamin D deficiency

16 Dec 2023

Among schoolchildren with a high baseline prevalence of vitamin D deficiency, oral supplementation with vitamin D for 3 years is safe but falls short of reducing the risk of fracture, according to a study.

Supplementation does little to reduce fractures in schoolchildren with vitamin D deficiency

16 Dec 2023

Teplizumab preserves ß-cell function in children with new-onset T1D

15 Dec 2023 by

Treatment with teplizumab significantly preserved beta(ß)-cell function, as measured by C-peptide levels, in children and adolescents with new-onset type 1 diabetes (T1D) compared with placebo, according to the PROTECT* study.

Teplizumab preserves ß-cell function in children with new-onset T1D

15 Dec 2023

Original New Drug Application Approvals by US FDA (16-30 November 2023)

13 Dec 2023

New drug applications approved by US FDA as of 16-30 November 2023 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

Original New Drug Application Approvals by US FDA (16-30 November 2023)

13 Dec 2023

Very early HIV treatment may help babies live medication-free

13 Dec 2023 by

Initiating antiretroviral therapy (ART) within 48 hours of life for infants born with HIV can lead to sustained viral suppression, as reflected by reduced HIV reservoirs by age 2 years, which suggests the possibility of an ART-free remission.

Very early HIV treatment may help babies live medication-free

13 Dec 2023

Extended depth of focus soft contact lenses slows myopia progression in children

13 Dec 2023

Wearing soft contact lenses with extended depth of focus reduces axial elongation and, in turn, delays the progression of myopia in children when compared with using distance single-vision spectacles, as shown in a study.

Extended depth of focus soft contact lenses slows myopia progression in children

13 Dec 2023

One in six CYPs in SG develop long COVID

11 Dec 2023 by

In Singapore, about one in six children and young persons (CYPs) developed long COVID, with persistence of ≥1 symptoms 3 months after an acute COVID-19 infection, a survey study suggests.

One in six CYPs in SG develop long COVID

11 Dec 2023

Novel therapies tied to drop in colectomy rate in paediatric UC

05 Dec 2023

The risk of colectomy in paediatric onset ulcerative colitis (UC) has significantly decreased at the population level along with an increase in the use of immunosuppressants and antitumour necrosis factor (anti-TNF), reports a study.

Novel therapies tied to drop in colectomy rate in paediatric UC

05 Dec 2023

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Original New Drug Application Approvals by US FDA (01-15 December 2023)

Original New Drug Application Approvals by US FDA (01-15 December 2023)

Zonulin a promising biomarker for preclinical coeliac disease screening

Zonulin a promising biomarker for preclinical coeliac disease screening

AI-guided stethoscope helps detect cardiomyopathy during pregnancy

AI-guided stethoscope helps detect cardiomyopathy during pregnancy

Supplementation does little to reduce fractures in schoolchildren with vitamin D deficiency

Supplementation does little to reduce fractures in schoolchildren with vitamin D deficiency

Teplizumab preserves ß-cell function in children with new-onset T1D

Teplizumab preserves ß-cell function in children with new-onset T1D

Original New Drug Application Approvals by US FDA (16-30 November 2023)

Original New Drug Application Approvals by US FDA (16-30 November 2023)

Very early HIV treatment may help babies live medication-free

Very early HIV treatment may help babies live medication-free

Extended depth of focus soft contact lenses slows myopia progression in children

Extended depth of focus soft contact lenses slows myopia progression in children

One in six CYPs in SG develop long COVID

One in six CYPs in SG develop long COVID

Novel therapies tied to drop in colectomy rate in paediatric UC

Novel therapies tied to drop in colectomy rate in paediatric UC